Helminth Infection During Pregnancy on Vitamin D Regulation: HELMVIT Study

Vitamin D Deficiency Clinical Trial

— HELMVIT  

Official title:

Assessing the Effect of Maternal Helminth Infection on Vitamin D Regulation and on the Immune System of the Infant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04324853
• Other study ID #: PROT N°038/2018/SG/CNE
• Status: Completed
• Start date: January 28, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Centre de Recherche Médicale de Lambaréné
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Purpose: To examine whether helminth infection during pregnancy alters Vitamin-D-metabolism and reactivity of the child's immune system Hypothesis: Helminth infection during pregnancy is associated with altered Vitamin D levels and Vitamin D receptor expression in the placenta and modified immune reactivity in the infant.

Description:

Objectives The primary objective of the proposed research project is to study the impact of helminth infection in general and particularly of infection with S. haematobium during pregnancy on Vitamin D metabolism and its related factors as well as the impact of maternal infection on infants developing immune system and health. Specific Objectives To assess the effect of maternal helminths infections on Vitamin D and vitamin-D-related factors in the serum of pregnant women and cord blood of their infants, To assess the effect of helminth infection on placental biology: Determine expression levels of VDR and inflammatory genes Investigate histologically the gestational age and other functional aspects of the placenta Determine the influence of helminth driven inflammation and helminth antigens on placental tissue by establishing a (co-)culture system using primary placental cells and a placental cell line To assess whether helminth infections influence the infant's peripheral immune system by analyzing composition, reactivity and lineage determination of fetal cord blood mononuclear cells (CBMCs) in relation to the maternal and fetal immune and Vitamin D status. Current study focusing objectives In the present study the investigators explore if and how Vitamin D and its related signals are modulated by helminth infection and how helminth infection could thereby shape the developing immune system of the newborn by analyzing CBMCs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women attending antenatal care from Lambaréné and Fougamou areas
• Pregnant women who have given written informed consent to the study for herself and for her unborn child and live infant.

Exclusion Criteria:

• Known of chronic infections and diseases(e.g. diabetes, HIV, Hepatitis B and C, anemia).

Related Conditions & MeSH terms

• Helminthiasis
• Immunosuppression
• Vitamin D Deficiency

Intervention

Diagnostic Test:
• Microscopy ( Urine filtration), UCAA test, qPCR,
Schistosomiasis is an acute and chronic parasitic disease caused by blood flukes (trematode worms) of the genus Schistosoma.Schistosomiasis is prevalent in tropical and subtropical areas, especially in poor communities without access to safe drinking water and adequate sanitation.
• Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR,
Soil-transmitted helminth infections are among the most common infections worldwide and affect the poorest and most deprived communities. They are transmitted by eggs present in human faeces which in turn contaminate soil in areas where sanitation is poor.

Locations

Country	Name	City	State
Gabon	Josiane Y Honkpehedji	Lambaréné	Moyen Ogooué

Sponsors (3)

Lead Sponsor	Collaborator
Centre de Recherche Médicale de Lambaréné	Technical University of Munich, University Hospital Tuebingen

Country where clinical trial is conducted

Gabon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between Schistosoma and helminth infection and Vitamin D levels.	Schistosoma hematobium in pregnancy is associated with vitamin D metabolism	48 Months
Secondary	Association between Schistosoma infection and intrauterine growth restriction (IUGR) (defined as birth weight below the 10th birth weight percentile), stillbirth and premature delivery.	Schistosoma hematobium infection during pregnancy is associated with a birth weight born child	48 Months